Process Engineer II, MSAT

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Process Engineer II, MSAT

Division/Site Specific Information

Our St. Louis, MO biologics development and manufacturing facility is a recognized Center of Excellence for bioprocessing and single-use technology (S.U.T.). The site features the Bioprocessing Collaboration Center (BCC) and the Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactors (S.U.B.s).

Here, our experts work with high-capital equipment and advanced resources to create customized and optimized process development and scale-up solutions for bispecifics, Fc-fusion proteins, IgG1, IgG4, and other complex protein-based biologics. This environment supports innovation, technical ownership, and close collaboration across manufacturing, development, and quality teams.

Discover Impactful Work

At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. As part of our global team of 100,000+ colleagues, you'll work alongside experts driven by our values of Integrity, Intensity, Innovation, and Involvement.

As a Process Engineer II, MSAT, you will play a critical role in supporting customer programs and internal technology initiatives by providing technical expertise across manufacturing, validation, and process improvement activities in a GMP biologics environment.

How Will You Make an Impact?

You will serve as a technical contributor and emerging technical owner for manufacturing processes, supporting the Process Engineering / MSAT team in a fast-paced, 24/7 biologics manufacturing facility. Through cross-functional collaboration with Operations, Quality Assurance, Process Development, and occasionally customers, you will help ensure robust, compliant, and scalable manufacturing solutions.

A Day in the Life

• Draft and maintain Standard Operating Procedures (SOPs) and Job Aids
• Collaborate with Process Development to assess standardized methodologies and learn new unit operations at manufacturing scale (cell culture, harvest, purification)
• Contribute to internal and customer meetings, supported by data and sound scientific rationale
• Manage internal projects and support client projects, including timeline management
• Identify error-proofing opportunities and drive engineering improvements to practices and procedures
• Provide scientific and technical support for GMP deviations, assessing impact to product quality and process validation
• Lead changes to equipment and process design
• Draft, review, and approve:
  
  • Manufacturing Batch Records
  • Performance Qualifications (PQs)
  • Process Validation protocols
  • Process Flow Diagrams
  • Automation methods
  • Bills of Materials (BOMs)
• Draft process control documents, campaign summary reports, and process validation reports
• Review, analyze, and trend process data with minimal supervision
• Provide technical feedback on documents from other departments (e.g., Tech Transfer Protocols, SOPs)
• Troubleshoot technical issues on the manufacturing floor, including on-call support and occasional weekend coverage
• Support site-wide MSAT initiatives focused on patient safety, compliance, and customer delivery
• Provide development and training support for Process Engineers and Scientists

Keys to Success

Education

• Bachelor's degree required in a scientific discipline; engineering preferred
• Master's degree may be considered in lieu of some experience

Experience

• 2+ years of experience in a GMP-regulated biologics or pharmaceutical manufacturing environment
• Working knowledge of current Good Manufacturing Practices (cGMPs) and EU regulations
• Experience supporting manufacturing, validation, or MSAT activities

Knowledge, Skills, and Abilities

Knowledge

• Foundation in general scientific principles and pharmaceutical manufacturing practices
• Basic understanding of statistical methods for pharmaceutical process analysis (preferred)

Skills

• Strong written and verbal communication skills
• Proficiency in Microsoft Word and Excel
• Ability to review, analyze, and trend manufacturing and process data

Abilities

• Ability to self-motivate, prioritize, and manage time effectively
• Ability to work independently and collaboratively in cross-functional teams
• Ability to gown and work in manufacturing environments and stand for prolonged periods

Physical Requirements / Work Environment

• Work in a GMP manufacturing environment
• Ability to gown into classified areas
• Ability to support a 24/7 manufacturing operation, including on-call and weekend coverage as needed

Excellent Benefits

Thermo Fisher Scientific offers a competitive compensation and benefits package, including:

• Medical, Dental, and Vision benefits effective Day 1
• Paid Time Off and designated paid holidays
• Retirement Savings Plan
• Tuition Reimbursement

Relocation assistance is not provided

Must be legally authorized to work in the United States now and in the future without sponsorship

Must be able to pass a comprehensive background check, including drug screening